DOCETAXEL HOSPIRA 10 MGML

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

DOCETAXEL

Tilgængelig fra:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC-kode:

L01CD02

Lægemiddelform:

SOLUTION FOR INFUSION

Sammensætning:

DOCETAXEL 10 MG / 1 ML

Indgivelsesvej:

I.V

Recept type:

Required

Fremstillet af:

HOSPIRA UK LTD, UK

Terapeutisk gruppe:

DOCETAXEL

Terapeutisk område:

DOCETAXEL

Terapeutiske indikationer:

Breast cancer: Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer. Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel monotherapy is indicated for the treatment of patients with metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent. Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previously have not received chemotherapy for metastatic disease. Docetaxel in combination with capecitabine is indicated for the treatment of patients with metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Doxorubicin and cyclophosphamide followed by Docetaxel in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with HER2 over-expressing, node-positive or high risk node-negative, breast cancer. Docetaxel in combination with trastuzumab, and carboplatin (TCH) is indicated for the adjuvant treatment of patients with HER2 over-expressing, node-positive or high risk node-negative, breast cancer. Non-small cell lung cancer: Docetaxel is indicated for the treatment of patients with advanced non-small cell lung carcinoma. Ovarian Cancer: Docetaxel is indicated for treatment of metastatic carcinoma of the ovary after failure of first line or subsequent chemotherapy. Prostate cancer: Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Esophageal cancer: Docetaxel for the treatment of esophageal cancer. Gastric cancer: Docetaxel for the treatment of advanced gastric cancer. Head and neck (SCCHN): Docetaxel as monotherapy in the treatment of patients with recurrent and/or metastasis squamos cell carcinoma of the head and neck after failure of a previous chemotherapy regimen. Docetaxel in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck

Autorisation dato:

2017-05-31

Indlægsseddel

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ךיראת
21.4.2013
םש
רישכת
תילגנאב
DOCETAXEL HOSPIRA 10 MG/ML
רפסמ
םושיר
148.24.33345.00
םש
לעב
םושירה
המראפהבונ
מ"עב
ספוט
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םי/שקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
SPECIAL
WARNINGS AND
SPECIAL
PRECAUTIONS
FOR USE
Current text:
In the case of severe
neutropenia (<500 cells/mm
3
for 7 days or more) during a
course of docetaxel therapy, a
reduction in dose for
subsequent courses of therapy
or the use of appropriate
symptomatic measures are
recommended (see section
“POSOLOGY AND METHOD OF
ADMINISTRATION”).
In patients treated with
docetaxel in combination with
cisplatin and 5-fluorouracil
(TCF), febrile neutropenia and
neutropenic infection occurred
at lower rates when patients
received prophylactic G-CSF.
Patients treated with TCF
should receive prophylactic
G-CSF to mitigate the risk of
complicated neutropenia
(febrile neutropenia,
prolonged neutropenia or
neutropenic infection).
Patients receiving TCF should
be closely monitored (see
section “POSOLOGY AND
METHOD OF ADMINISTRATION”
and “UNDESIRABLE EFFECTS“).
Congestive heart failure:
Patients should be monitored
for symptoms of congestive
Change to the following text:
In the case of severe neutropenia
(<500 cells/mm
3
for 7 days or
more) during a course of
docetaxel therapy, a reduction in
dose for subsequent courses of
therapy or the use of appropriate
symptomatic measures are
recommended (see section
“POSOLOGY AND METHOD OF
ADMINISTRATION”).
In patients treated with
docetaxel in combination with
cisplatin and 5-fluorouracil
(TCF), and docetaxel in
combination with doxorubicin
and cyclophosphamide (TAC),
febrile neutropenia and
neutropenic infection occurred
at lower rates when patients
received prophylactic G-CSF.
Patients treated

Produktets egenskaber

Docetaxel Hospira 10mg/ml LPD CC technical change 040219
2019-0047589
1
DOCETAXEL HOSPIRA
® 10 MG/ML
1.
NAME OF THE MEDICINAL PRODUCT
DOCETAXEL HOSPIRA
®
10 MG/ML.
WARNING: TOXIC DEATHS, HEPATOTOXICITY, NEUTROPENIA,
HYPERSENSITIVITY REACTIONS AND FLUID RETENTION
THE INCIDENCE OF TREATMENT-RELATED MORTALITY ASSOCIATED WITH DOCETAXEL
THERAPY IS
INCREASED IN PATIENTS WITH ABNORMAL LIVER FUNCTION, IN PATIENTS
RECEIVING HIGHER DOSES,
AND IN PATIENTS WITH NON-SMALL CELL LUNG CARCINOMA AND A HISTORY OF
PRIOR TREATMENT WITH
PLATINUM-BASED CHEMOTHERAPY WHO RECEIVE DOCETAXEL AS A SINGLE AGENT AT
A DOSE OF
100 MG/M2.
DOCETAXEL SHOULD NOT BE GIVEN TO PATIENTS WITH BILIRUBIN > UPPER LIMIT
OF NORMAL
(ULN), OR TO PATIENTS WITH AST AND/OR ALT >1.5 × ULN CONCOMITANT WITH
ALKALINE
PHOSPHATASE >2.5 × ULN. PATIENTS WITH ELEVATIONS OF BILIRUBIN OR
ABNORMALITIES OF
TRANSAMINASE CONCURRENT WITH ALKALINE PHOSPHATASE ARE AT INCREASED
RISK FOR THE
DEVELOPMENT OF GRADE 4 NEUTROPENIA, FEBRILE NEUTROPENIA, INFECTIONS ,
SEVERE
THROMBOCYTOPENIA, SEVERE STOMATITIS, SEVERE SKIN TOXICITY, AND TOXIC
DEATH. PATIENTS WITH
ISOLATED ELEVATIONS OF TRANSAMINASE >1.5 × ULN ALSO HAD A HIGHER RATE
OF FEBRILE
NEUTROPENIA GRADE 4 BUT DID NOT HAVE AN INCREASED INCIDENCE OF TOXIC
DEATH. BILIRUBIN,
AST OR ALT, AND ALKALINE PHOSPHATASE VALUES SHOULD BE OBTAINED PRIOR
TO EACH CYCLE OF
DOCETAXEL THERAPY.
DOCETAXEL THERAPY SHOULD NOT BE GIVEN TO PATIENTS WITH NEUTROPHIL
COUNTS OF <1500
CELLS /MM. IN ORDER TO MONITOR THE OCCURRENCE OF NEUTROPENIA, WHICH
MAY BE SEVERE AND
RESULT IN INFECTION, FREQUENT BLOOD CELL COUNTS SHOULD BE PERFORMED ON
ALL PATIENTS
RECEIVING DOCETAXEL.
SEVERE HYPERSENSITIVITY REACTIONS CHARACTERIZED BY GENERALIZED
RASH/ERYTHEMA,
HYPOTENSION AND/OR BRONCHOSPASM, OR VERY RARELY FATAL ANAPHYLAXIS,
HAVE BEEN REPORTED
IN PATIENTS WHO RECEIVED A 3-DAY DEXAMETHASONE PREMEDICATION.
HYPERSENSITIVITY
REACTIONS REQUIRE IMMEDIATE DISCONTINUATION OF THE DOCETAXEL INFUSION
AND
ADMINISTRATION OF APPROPRIATE THERAPY. DOCETAXEL MUST NOT BE GIVEN TO
PATIENT